- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03534882
Effects of Prostaglandin Analogue Washout Following Long-term Therapy in Adults With Primary Open Angle Glaucoma
Prospective, Randomized, Single-blind Controlled Trial of Topical Prostaglandin Analogue Washout Following Chronic Monotherapy in Adults With Suspected or Proper Primary Open Angle Glaucoma
Study Overview
Status
Intervention / Treatment
Detailed Description
Quality assurance plan: Paper copies of all registry data is securely stored at the site of data collection. Registry data is first de-identified and then stored in an encrypted Master data excel sheet that only research staff have access to.
Data Checks and Source Data Verification: Data is monitored closely and re-assessed frequently by multiple members of the research team to ensure the accuracy of the Master data excel sheet. Registry data will be compared to paper registry copies and patient medical records to ensure accuracy and completeness.
Standard Operating Procedures:
All patients currently being seen by Dr. Hutnik (~6000) will have their charts reviewed. Personal information will be recorded to allow research staff to contact eligible participants. Clinical information recorded includes: diagnosis, intraocular pressure (IOP) at baseline, IOP at subsequent follow up visits with medication use, medication history, surgical and laser intervention history, visual acuity at baseline and follow-up visits, and visual field mean deviation. Patients fulfilling the inclusion and having none of the exclusion criteria are contacted via telephone by the research staff to invite them to participate in the trial. If they are interested, participants are met with in-person and provided with an information package including a form of consent. Research staff provide detailed description of this study's protocol, risks, and benefits for the patient prior to obtaining informed consent. Patients are also provided with the research teams' contact information should they have any questions or concerns. As part of the information package, participants receive notice that should they experience worrisome signs and symptoms, they should contact their ophthalmologist's office immediately. Following enrolment, participants are given an enveloped that randomizes them two either the control group (continues their eye drop medications) or experimental group (temporarily discontinues eye drop medications). In order to eliminate measurement bias, this allocation is concealed to research staff until completion of the trial. Participants' IOP is measured by Goldmann applanation tonometry at day of allocation (Day 0) and subsequently 7, 21, and 42 days after. In addition, should their IOP increase back to baseline levels prior to their final day of pressure measurement, participants are asked to restart their eye drops and are closely followed to ensure their IOPs return back to their pre-study values. Paper copies of participant signed consent and information form are stored in the research database. Once the assessment is complete, all participants will be debriefed on the nature of the study and potential findings. At the end of trial, participants will resume standard therapy according to Canadian Ophthalmology Society (COS) 2009 Glaucoma Guidelines.
Power analysis using a General Linear Multivariate Model for Power and Sample Size (GLIMMPSE) found that a total patient N value of 87 (154 eyes) was sufficient power for our study
Missing Data: All missing data is documented in the Master data record and will be reported. Participants with missing baseline (pre-treatment) IOP values are excluded from the study. Within-study missing IOP values are accounted for in statistical analysis.
Statistical analysis: Statistical analysis is performed on R. Data is analyzed using a linear mixed effects model fit by restricted maximum likelihood (REML) t-tests with Satterthwaite approximations to compare mean intraocular pressure between control and washout groups at day 0, 7, 21, and 42.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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London, Ontario, Canada, N6A 4V2
- Ivey Eye Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of glaucoma or or ocular hypertension
- Prostaglandin analogue responder >20% intraocular pressure (IOP) reduction from baseline
- Age >18 years
- Baseline IOP (pre-treatment) ≥21 mmHg
- Prostaglandin analogue treatment duration > 6 months
Exclusion Criteria:
- Diagnosis of acute angle closure glaucoma
- Treatment with > 1 glaucoma medication
- Topical steroid > 3 consecutive weeks
- Intraocular surgery in last 6 months prior to enrollment
- Glaucoma laser intervention in last 12 months prior to enrollment
- Best Corrected Visual Acuity (BCVA) < 70 letters (EDTRS or Snellen equivalent)
- Visual field mean deviation <-3
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Washout
Discontinuation of topical prostaglandin analogue therapy: Participants are asked to discontinue (washout) their prostaglandin analogue for 42 days.
As the experimental group, the purpose of this arm is to determine the lingering IOP-reducing effects following discontinuation of chronic prostaglandin analogue therapy, and to determine if IOP rises back to baseline (pre-treatment values).
|
Participants are asked to discontinue their prostaglandin analogue eye drops for the designated time period (42 days)
Other Names:
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No Intervention: Control
Patients are asked to remain on their prostaglandin analogues and continue treatment as prescribed by their ophthalmologist.
The purpose of this arm is to minimize bias in intraocular pressure readings.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Day 42 Intraocular Pressure (mmHg)
Time Frame: 42 days after starting trial
|
Measured by Goldmann Applanation Tonometer
|
42 days after starting trial
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Day 7 Intraocular Pressure (mmHg)
Time Frame: 7 days after starting trial
|
Measured by Goldmann Applanation Tonometer
|
7 days after starting trial
|
Day 21 Intraocular Pressure (mmHg)
Time Frame: 21 days after starting trial
|
Measured by Goldmann Applanation Tonometer
|
21 days after starting trial
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cindy ML Hutnik, MD, PhD, Western University, Department of Ophthalmology
Publications and helpful links
General Publications
- Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. doi: 10.1001/archopht.120.6.701.
- Tataru CP, Purcarea VL. Antiglaucoma pharmacotherapy. J Med Life. 2012 Sep 15;5(3):247-51. Epub 2012 Sep 25.
- Lee R, Hutnik CM. Projected cost comparison of selective laser trabeculoplasty versus glaucoma medication in the Ontario Health Insurance Plan. Can J Ophthalmol. 2006 Aug;41(4):449-56. doi: 10.1016/S0008-4182(06)80006-2.
- Kreidler SM, Muller KE, Grunwald GK, Ringham BM, Coker-Dukowitz ZT, Sakhadeo UR, Baron AE, Glueck DH. GLIMMPSE: Online Power Computation for Linear Models with and without a Baseline Covariate. J Stat Softw. 2013 Sep;54(10):i10. doi: 10.18637/jss.v054.i10.
- Lim CW, Diaconita V, Liu E, Ault N, Lizotte D, Nguyen M, Hutnik CML. Effect of 6-week washout period on intraocular pressure following chronic prostaglandin analogue treatment: a randomized controlled trial. Can J Ophthalmol. 2020 Apr;55(2):143-151. doi: 10.1016/j.jcjo.2019.08.004. Epub 2019 Nov 8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4834 (Other Identifier: OHSU IRB (discontinued number))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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